Feedback on changes to the Drug and Pharmacies Regulation Act
Ontario Regulation 58/11
Quote from Regulation
Remote dispensing location
2. For purposes of the Act and this Regulation, “remote dispensing location”
means:
(a) in a pharmacy that is accredited as a community pharmacy, a place
where drugs are dispensed or sold by retail to the public under the
supervision of a pharmacist who is not physically present; and
Comments
This definition would include Automated
Dispensing Unit's in the patient care areas. This
section needs to be clear that the drug is
supplied directly to the patient from the
machine not via a nurse.
(b) in a pharmacy that is accredited as a hospital pharmacy, a place
where drugs are dispensed or supplied to patients of the hospital under
the supervision of a pharmacist who is not physically present.
Classes of accreditation
7. (1) The following classes of accreditation are hereby established:
In the act there is also provision for institutional
pharmacies why is there no regulations related
to these entities described.
(a) community pharmacy; and
(b) hospital pharmacy.
Classes of accreditation
7. (2) A pharmacy that holds a certificate of accreditation to operate a pharmacy
as of the date this Regulation comes into force is deemed to be accredited as a
community pharmacy.
Qualifications for the issuance of a certificate of accreditation of any class
8. (1) An applicant is qualified for the issuance of a certificate of accreditation to
establish and operate a pharmacy of any class if:
(4) The past and present conduct of each person who is an applicant, and in the
case of a corporation, of each director, and of each shareholder who directly or
indirectly owns five percent or more of the voting shares of that corporation,
affords reasonable grounds for the belief that the pharmacy will be operated
with decency, honesty and integrity and in accordance with the law.
Issuance, name and address
11. (1) A certificate of accreditation shall be issued in the specific name of the
person who owns the pharmacy and for the specific municipal address or
addresses at which the pharmacy is to be operated.
Expiry of certificates of accreditation
13. (5) Where the Accreditation Committee directs the Registrar not to renew the
certificate of accreditation of a pharmacy, the certificate of accreditation shall be
deemed to have expired as of the date the decision of the Accreditation
Committee becomes final.
When a hospital pharmacy holds a certificate of
accreditation what is it deemed to be since only
community is addressed here.
Hospital board of directors do not own shares of
the hospital pharmacy and how will their past
and present conduct be assessed and do they
need to apply for accreditation? Is it all
members of the board or just the Chair.
For a hospital the owner is defined as the
directors of the corporation. Will the certificate
be issued in the director's name? If ADU's are
remote dispensing locations then will all
directors need to be listed?
The Minister needs to be informed before any
action can be taken.
Qualifications for renewal of any class
14. (1) An owner is qualified for the renewal of a certificate of accreditation if:
Qualifications for renewal of any class
14. (2) A certificate of accreditation shall not be renewed where an inspection of
the pharmacy or of any of its remote dispensing locations has taken place under
the Act and where the inspector identified a failure to conform to the
requirements of the Act and its regulations that poses a risk of harm to the
public, unless the Registrar is satisfied that such failure has been addressed either
to the Registrar’s satisfaction or, failing that, to the satisfaction of the
Accreditation Committee.
Revocation
Owner is defined as all the directors of the
corporation. Do all of them need to sign the
application?
In the act as per section 166.1 of the act the
minister needs to be informed before action is
taken.
Again after the Minister is informed
16. (2) The Accreditation Committee may direct the Registrar to revoke a
certificate of accreditation where it is satisfied that it was issued or renewed
based on the false or misleading information of an applicant or owner and where
it is satisfied that it is appropriate to do so.
Standards for accreditation of any class
18. (2) Every owner and designated manager shall ensure that the standards for
accreditation of a pharmacy are maintained.
Requirements of a pharmacy
19. Every pharmacy must,
Requirements of a pharmacy
19. Every pharmacy must,
(g) have information management systems that,
Will hospitals require a designated manager and
if not then who is ensuring that standards for
accreditation are maintained? Will it be the
board members? This is not practical.
Where do the hospital assessment standards fit
into the accreditation process? They are not
mentioned here and are not a requirement for
accreditation.
Does this mean that every pharmacy must have
a computer system or does it mean that if they
have a computer system then that system must
meet these requirements.
(i) support the delivery of patient care,
(ii) permit information to be recorded, displayed, stored and exchanged; and
(iii)facilitate information exchange with external systems, while preserving the
confidentiality, security and integrity of all personal information;
Requirements of a pharmacy
19. Every pharmacy must,
(j) have the Symbol clearly displayed so as to be easily visible to patients or the
public either before or immediately after entering the pharmacy; and
Requirements of a pharmacy
19. Every pharmacy must,
(k) have systems in place to maintain an audit trail of the acquisition and
Where would this symbol be located? Often the
hospital pharmacy is not clearly identified to the
public for security purposes since often they will
not need to access the location. If this symbol is
displayed outside the pharmacy then there is a
risk. If placed inside the pharmacy then no one
outside of pharmacy staff will see it. What is
the purpose?
What does an audit trail mean? We know what
we buy and what we send to the units but we
do not have full traceability of lot and expiry. Is
this required by the time the regulations come
movement of drugs.
into force?
Recordkeeping
There is no electronic system on the market
that supports electronic retention of records
that is auditable and traceable. Are hospital
pharmacies expected to scan all their
documents related to dispensing? Where
would they scan the documents and where
would they be kept?
20. (2) The records and documents referred to in subsection (1) shall be
maintained in the pharmacy in an electronic format and in a manner that is
secure, auditable, traceable and allows for their easy retrieval.
Length of retention
21. Subject to the Act, records and other documents relating to the care of a
patient shall be maintained for a period of at least 10 years from the last
recorded pharmacy service provided to the patient, or until 10 years after the
day on which the patient reached or would have reached the age of 18 years,
whichever is longer.
Access and supervision
24. A remote dispensing location shall only be accessible to the public or to
hospital patients, as applicable, when a pharmacist:
Controlled drugs, narcotic drugs and targeted substances
26. No controlled drugs, narcotic drugs, verbal prescription narcotics or targeted
substances shall be located at or available from a remote dispensing location.
Information and notices to be displayed
27. (1) At every remote dispensing location, contact information for the
pharmacy under whose certificate of accreditation the remote dispensing
location operates shall be clearly and prominently displayed.
Acts of proprietary misconduct
32. The following are acts of proprietary misconduct for the purpose of section
140 of the Act:
Patients come and go from the hospital
therefore it is unknown when the last recorded
pharmacy service will be therefore this would
mean that hospitals would need to know when
patients die since that is the only guarantee that
they will not return and keep the records for 10
years after that. This is not the standard for
record retention in health records.
Is this the ADU? Public and hospital patients
would never have access.
ADU's need to contain narcotics and controlled
drugs and targeted substances.
This whole section does not make sense for
ADU's. They are unit dose medications
removed from the machine by nurses at the
point of administration and therefore the
signage on the machine and the product would
not make sense.
They are no longer called inspectors but rather
advisors
4. Failing to co-operate with an inspector of the College.
Acts of proprietary misconduct
32. The following are acts of proprietary misconduct for the purpose of section
140 of the Act:
Currently no hospital pharmacy can comply with
the records outlined above.
7. Failing to keep records as required respecting the operation of the pharmacy
and the patients and practice of members practising in the pharmacy.
Acts of proprietary misconduct
32. The following are acts of proprietary misconduct for the purpose of section
140 of the Act:
Prescription information is always disclosed to
those members in the circle of care for the
patient. For example when a patient is
transferred to another institution. In addition
prescription information needs to be available
to the nurse administering the medication. In a
retail store prescription information is always
11. Disclosing prescription information to another person unless: (i) the
disclosure is made in accordance with a written agreement between the owner
and the person to whom the disclosure is made, and that agreement requires
that any prescription information that is disclosed will not include anything that
would be reasonably expected to identify a patient; and
disclosed to the payor of the prescription.
Acts of proprietary misconduct
Patients in a hospital do not have a choice of
pharmacy or pharmacist. Therefore this section
would be contravened in a hospital.
32. The following are acts of proprietary misconduct for the purpose of section
140 of the Act:
18. Entering into any agreement that restricts a person’s choice of a pharmacy or
pharmacist without the consent of that person.
Acts of proprietary misconduct
32. The following are acts of proprietary misconduct for the purpose of section
140 of the Act:
20. In a pharmacy that is accredited as a hospital pharmacy, returning to stock or
selling or dispensing again a drug, that was previously sold or dispensed, except
that it will not be proprietary misconduct to return to stock or re-sell or redispense a drug (i) that is returned to the pharmacy in a sealed dosage unit or
container as originally dispensed,
This would only be possible in a unit dose
system. If a traditional or ward stock system
were used in the hospital which is very
common, then this could not be done because
vials would be redispensed and these are not
sealed. Oral liquid syringes are also not sealed.
ie. does it mean a sealed container or just the
original container?
(ii) that is returned with the labelling intact and includes a legible drug lot
number and expiry date, and
(iii) the integrity of which can be verified.
21. Dispensing, selling or compounding a drug, or administering a substance, that
is not of good quality or does not meet the standards required by law, or, in the
case of a drug, does not contain a substance that the drug is meant to contain.
Acts of proprietary misconduct
32. The following are acts of proprietary misconduct for the purpose of section
140 of the Act:
Pharmacists can administer the flu shot
therefore why is it professional misconduct to
pierce the dermis?
27. Contravening any federal, provincial or territorial law or any municipal bylaw, (i) with respect to the distribution, purchase, sale, or dispensing or
prescribing of any drug product, the administering of any substance, or the
piercing of the dermis,
Conflict of interest, definitions
33. In this section, and in sections 34 and 35,
“responsible person” means the designated manager and the owner of the
pharmacy;
Hospitals do not have designated managers.